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Description
To facilitate efficient operations and timely progress in your projects, it is crucial to implement a well-defined document control procedure that enhances the flow of information. Integrating this document control process within a project document management system ensures that every team member follows the established guidelines, from document creation to approval and distribution, ultimately leading to improved quality and consistency in deliverables for clients. Typically, a document control procedure for engineering drawings, which encompass technical documentation, should also include key details such as the document owner's information, a numbering system, revision history, and the identities of reviewers and approvers. Utilizing a document control tool enables you to verify that all these essential elements are addressed prior to publication, ensuring that the information remains accurate and easily accessible. This approach not only streamlines operations but also fosters accountability among team members throughout the project lifecycle.
Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Microsoft Entra ID
Pricing Details
$899 per month
Free Trial
Free Version
Pricing Details
$13,750/year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
AGTIV Consulting
Founded
2008
Country
Malaysia
Website
www.agtiv.com
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
Product Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management